Effect of Collagenase on Healing and Scarring

About this trial

Last updated 15 years ago

Study ID

017 101 09 001

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18 to 50 Years

All Sexes

Trial Timing

Ended 16 years ago

What is this trial about?

A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.

What are the participation requirements?

Inclusion Criteria

1. Provide written informed consent

2. Willing to attend all required study visits

Exclusion Criteria

1. Known hypersensitivity to Clostridial collagenase

2. Anticoagulants (blood thinners, including aspirin) within two weeks

3. Congenital skin disorder which affects keratinocytes, elastin, or collagen

4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure

5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding

6. At risk of keloid or hypertrophic scar formation

7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed

8. Any skin disorder which causes delayed healing

9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome

10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs